MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-30 for QUALITY ELECTRODYNAMICS Q7000008, Q7000016, Q7000019, Q7000050, Q7000051, manufactured by Quality Electrodynamics, Llc.
| Report Number | 3007350713-2019-08291 |
| MDR Report Key | 8952588 |
| Date Received | 2019-08-30 |
| Date of Report | 2019-08-29 |
| Date Mfgr Received | 2019-08-01 |
| Device Manufacturer Date | 2019-05-29 |
| Date Added to Maude | 2019-08-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KATHLEEN ARAS |
| Manufacturer Street | 6655 BETA DRIVE SUITE 100 |
| Manufacturer City | MAYFIELD VILLAGE OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal | 44143 |
| Manufacturer Phone | 4404842964 |
| Manufacturer G1 | QUALITY ELECTRODYNAMICS, LLC |
| Manufacturer Street | 6655 BETA DRIVE SUITE 100 |
| Manufacturer City | MAYFIELD VILLAGE OH 44143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | QUALITY ELECTRODYNAMICS |
| Generic Name | RADIO FREQUENCY COILS FOR USE WITH MAGNETIC RESONANCE SCANNERS |
| Product Code | MOS |
| Date Received | 2019-08-30 |
| Model Number | Q7000008, Q7000016, Q7000019, Q7000050, Q7000051, |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUALITY ELECTRODYNAMICS, LLC |
| Manufacturer Address | 6655 BETA DRIVE SUITE 100 MAYFIELD VILLAGE OH 44143 US 44143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2019-08-30 |